Technical File

In CE marking, you have to comply to the requirements of the directive, to demonstrate the compliance with the requirements, the evidences must be filed which is called as a technical file of the product. The technical file cover almost all the documents which can demonstrate the compliance of your product with the requirements which are laid down by the directive, the technical file must have all applicable information about your product.

The following are the list of enclosures….

  1. Description of the product (model, name, etc...)
  2. Intended use of the device
  3. Manufacturing process.
  4. List of accessories.
  5. Manufacturing facilities.
  6. Classification of the device and rationale for classification.
  7. Route of CE Marking
  8. EC Declaration of Conformity
  9. Lifetime/shelf life of products.
  10. Medical Device Reporting procedure.
  11. European Authorized Representative agreement
  12. Subcontractor names and addresses, if applicable.
  13. Essential Requirements.
  14. Design input specifications.
  15. List of Harmonized Standards
  16. Testing Reports & Validation Reports
  17. Clinical evaluations.
  18. Risk analysis.
  19. Instructions for Use and Labeling

Technical File Vs Design Dossier
A design dossier is an expanded technical file which has to be pre-submitted to the notified body, instead of being only submitted upon request.
Technical file is used for medical device of class I, class IIa, and class IIb. The term Design dossier is used for the class III products

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